Reporting to the VP, Global Medical Safety (GMS), this individual will be responsible for leading and working collaboratively to assess, track and document the ongoing benefit-risk profile of all marketed products and those in development. This includes contributing to the safety sections of numerous aggregate reports (e.g., DSUR, PBRER, ASR), coordinating cross functional Safety Review Team (SRT) meetings, ensuring the completion of signal detection activities, and directing appropriate resource to all clinical development and product registration activities. This role is based in our Lexington office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.
Responsibilities (including, but not limited to):
Interact across multiple functions, lead the GMS operational activities and support senior levels of the organization
Safety Review Team meetings, and Signal Detection Activities:
Ensure delivery of the technical and scientific support for safety surveillance and signal detection activities for assigned products via established signal detection methodology and tools. Evaluate signals promptly in signal detection reports and ad-hoc responses to regulatory authorities in collaboration with GMS Medical lead
Efficiently plan Internal Safety Review Committee (SRC) and Safety Review Team (SRT) meetings, ensuring that stakeholders provide input from their respective areas of responsibility.
Contribute to safety sections of Risk Management Plans (RMPs) and other appropriate Regulatory process driven documents, if needed - ensuring that "safety sections" are completed and consulted upon.
Support for investigational products and registration activities:
Effectively collaborate with stakeholders outside of GMS.
Represent GMS department in cross-functional clinical programs and registrational activities and provide GMS support for clinical developmental programs.
Aggregate report production:
Oversee coordination and contribution to the production of periodic and ad-hoc safety reporting for therapeutic team products.
Create safety content and coordinates, with Regulatory Affairs and Medical Writing, the completion of aggregate reports (e.g. PBRER, DSUR, PADER, as well as ad hoc queries or reports) for submission to regulatory agencies.
Collaborates with the Vice President and Medical Lead to ensure that all information is available to allow for informed medical review and benefit-risk assessment.
Responsible for the quality of the safety sections of relevant final document and providing an overall review.
Support clinical development products in early stage (P1 and P2):
Work with clinical development stakeholders to develop early-stage trial design
May act as a manager for a product or group of products. Oversee and assume responsibility for assigned therapeutic products and PV activities through the lifecycle of the product. May include review of compliance in PV function and/or working directly with Kiniksa compliance staff.
Qualifications:
Requires a bachelor's degree in Life Sciences or Healthcare (Advanced degree, PharmD preferred)
10+ years work experience with relevant experience in Safety/Pharmacovigilance
Experience in the support of development products OR equivalent for drug product candidates in research settings
Good understanding of drug pharmacology strongly preferred.
Understanding of the clinical development and relevant regulatory process
Practical experience in the interpretation of global Pharmacovigilance regulations and implementation within an industry setting preferred. Alternatively demonstrate interchangeable skillset in healthcare related field
Competence in conducting safety data reviews for investigational and/or post marketed products or equivalent experience in healthcare or research setting.
Ability to contribute to and review standard operating procedures and other process-related documents
Excellent communication, collaboration and networking skills
Ability to influence others within a matrix environment
Must be able to work in a fast-paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demands
Ability to work independently, take initiative and complete tasks to deadlines
Forward planning and proactive
Support global decision-making and direction setting, including devising of future strategy and the management of complex tasks
Strong commitment to compliance and ethical standards
Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
Salary is commensurate with experience
Kiniksa Benefits Summary - USA
Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.